Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 17,874 FDA drug recalls.

DateProductReasonClassFirm
Jun 1, 2020 Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL... Subpotent Drug: Product was found to be subpotent. Product also has high pH levels Class II WORLD EVENT PROMOTIONS, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only ... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tabl... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, ... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distribut... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 coun... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only,... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only... Presence of Particulate Matter: particulate matter identified after reconstitution. Class II Pfizer Inc.
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only,... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 28, 2020 Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 ... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020 oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Inject... Subpotent drug - Product did not contain drug. Class II QuVa Pharma, Inc.
May 28, 2020 Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: ... Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. Class II Lupin Pharmaceuticals Inc.
May 28, 2020 Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single p... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020 Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distrib... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020 Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-... Presence of Foreign Substance consistent with granules from desiccant packs used during storage Class III AVKARE Inc.
May 28, 2020 Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distri... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 27, 2020 Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ... Failed Dissolution Specifications Class III Pfizer Inc.
May 27, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable in... Class II Apotex Inc.
May 26, 2020 Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III Aurobindo Pharma USA Inc.
May 26, 2020 Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... Presence of Foreign Substance visually consistent with the silica granules present in the desicca... Class III Jubilant Cadista Pharmaceuticals, Inc.
May 26, 2020 Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III Aurobindo Pharma USA Inc.
May 26, 2020 Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manuf... Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low lev... Class III UNICHEM PHARMACEUTICALS USA INC
May 22, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Some bottles may contain mixed strengths of the product. Class II Teva Pharmaceuticals USA
May 22, 2020 NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx O... Superpotent Drug. Class I Acella Pharmaceuticals, LLC
May 22, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Some bottles may contain mixed strengths of the product. Class II Teva Pharmaceuticals USA
May 22, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Some bottles may contain mixed strengths of the product. Class II Teva Pharmaceuticals USA
May 22, 2020 NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx... Superpotent Drug. Class I Acella Pharmaceuticals, LLC
May 22, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto... Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l... Class II The Harvard Drug Group
May 22, 2020 NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles... Superpotent Drug. Class I Acella Pharmaceuticals, LLC
May 19, 2020 LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... Class II American Health Packaging
May 19, 2020 LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches pe... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 pat... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertent... Class III Flexion Therapeutics, Inc.
May 15, 2020 Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa,... Failed impurities/ degradation specifications: Out of specification for organic impurities. Class II TRIOVA PHARMACEUTICALS LLC
May 15, 2020 EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate... Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allow... Class II Eco Lips Inc
May 15, 2020 Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... Failed dissolution specifications Class II PD-Rx Pharmaceuticals, Inc.
May 14, 2020 Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... Class III InvaGen Pharmaceuticals, Inc.
May 13, 2020 Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... Class II West-Ward Columbus Inc
May 13, 2020 Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. b... Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degra... Class III West-Ward Columbus Inc
May 11, 2020 Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Curcumin, 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.